FDA panel recommends loosening regulations for some peptides
The FDA panel is reviewing seven peptides and deciding if they should be added to a list of substances that can be safely produced by compounding pharmacies.
A Food and Drug Administration advisory panel voted on Thursday to broaden access to at least four peptides, amid a surge of interest in the unapproved therapies.
The vote took place during a two-day meeting discussing whether compounding pharmacies can fill prescriptions for some unapproved peptides.
Peptides are short strings of amino acids, the building blocks of proteins, linked by chemical bonds. The human body naturally produces some peptides, and more than 80 peptides have been approved for use by the FDA. Those approved peptides can be found in things like insulin, skincare products and GLP-1 medications.
Recently, there has been a surge in demand for unapproved peptides, which are typically sold as "research use only" and lack scientific evidence, such as clinical data or human trials, to back up their claims. Some unapproved peptides advertised by influencers online claim to be able to slow aging or increase muscle growth. Health and Human Services Secretary Robert F. Kennedy Jr. said he is a "big fan" of the unapproved therapies and that he has used them to help with injuries.
The panel reviewed four peptides during the first day of its two-day meeting, and voted 8-6 that each should be added to a list of substances that can be safely produced by compounding pharmacies, which mix medications that aren't available from standard drugmakers. Patients will need a doctor's prescription and need to take the therapy for a specific medical condition. The decision does not constitute FDA approval. Telehealth companies are expected to increase marketing for the therapies following the ruling, The Associated Press reported.
In its first session Thursday, the panel discussed the peptide BPC-157, which is one of the most popular among longevity and wellness influencers. It is marketed as being able to heal injuries and reduce inflammation.
NYU Langone's Dr. Rachel Pessah-Pollack told "CBS Mornings" that BPC-157 has only been tested in about 30 humans, as compared to the hundreds of thousands of patients GLP-1s were tested on.
"Anecdotes are not evidence," Pessah-Pollack said Thursday, ahead of the panel.
The other peptides added to the list are known as TB-500, MOTS-c and KPV. Three more peptides will be discussed on Friday.
Dr. Jessica Duncan, the chief medical officer for IVIM Health, a for-profit company that prescribes FDA-approved peptides, said she believes that because there is demand for the unapproved therapies, the FDA should work to ensure they can be provided by doctors.
"People want them. They have proven to us that they are going to
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